Closures for packages of biological products



June 23, 1959 J. U. GOULD 2,891,689

CLOSURES FOR PACKAGES OF BIOLOGICAL PRODUCTS Filed July 6, 1955 2 Sheets-Sheet 1 5 2? 4 27 f9 f1 I. T 2 13 15 W 25 24 27 4 Z7 2 z; P0

ATTO N E Y5 June 23, 1959 J. u. GOULD 2,8 1,6

CLOSURES FOR PACKAGES OF BIOLOGICAL PRODUCTS 7 Filed July 6, 1955 2' Sheets-Sheet 2 ENTOR INV flak ll Goadd B ATTO United States Patent Ofifice 2,891,689 Patented June 23, 1959 CLOSURES FOR PACKAGES OF BIOLOGICAL PRODUCTS Jack U. Gould, Brooklyn, N.Y., assignor to Ferdinand Gutmann & (10., a corporation of New York Application July 6, 1955, Serial No. 520,227

3 Claims. (Cl. 215-38) The present invention relates to bottle closures that have the specialized utility of assuring maintenance of sterility after withdrawal of part of the bottle contents by a hypodermic syringe.

As conducive to a clear understanding of the invention, it is noted that where a rubber stopper with a hollow shank is plugged into the bottle neck, frictionally to plug the bottle and to seat against the bottle rim, followed by application of a metal cap thereover, drawbacks are encountered. Among these are (1) that the stopper must be soft for self-sealing after puncture by a hypodermic needle, and insertion of such soft rubber stopper into the bottle neck is a slow and therefore a costly operation; (2) as the rubber stopper is forced into position, the air above the biologic product within the bottle may be trapped and greatly compressed, so that there is a tendency for the stopper to be propelled partly out of the bottle in subsequent expansion of such compressed air. This results in difliculty in applying the cap over the protruding stoppers and further prevents reliable seating of the flange of the stopper against the bottle rim. (3) The cost of stoppers by reason of their bulk and shape is high. (4) It is difiicult and costly to wash stoppers clean and completely to dry them in order to guard against trapping of air in applying the stopper. Attempts to maneuver the stopper into the bottle obliquely for venting of air further retard the assembly operation, and resort to stoppers with shanks that are ribbed to facilitate venting of air in insertion, each adds to the cost, and both expedients are at best only partly satisfactory. The attempt to make the plug portion of the stopper harder and smoother, while leaving the top portion soft, leads to complications of manufacture.

Where, on the other hand, a flat rubber disc is preassembled into a cap of the type, the central part of which is to be severed for access by the needle of a hypodermic syringe, there are also drawbacks. Among these are (1) the considerable difficulty in washing clean and completely drying such two pre-assembled elements; (2) the production of small particles of the metal of the cap during its fabrication which cling to the rubber gasket and cannot be entirely removed by washing and which may later fall into the biologic product; and (3.) a flat rubber disc entails corresponding cost, where its thickness is adequate to assure re-sealing of the rubber gasket upon removal of the hypodermic needle that punctures it for withdrawal of biologic material from the bottle.

It is accordingly among the objects of the present invention to provide a bottle closure for the specific utility above referred to, which effects economy in the amount of costly rubber required, dispenses with the need of expensive special constructions of stopper, which obviates the difliculties above pointed out with the use of stoppers, which affords an adequate thickness of rubber for assuring complete re-seal after withdrawal of the needle of a hypodermic syringe, and yet assures adequate seal against the rim of the bottle neck, and which afiords ready facilities for access to the rubber or other elastomer for withdrawal of part of the bottle contents.

According to the invention, the closure involves the use of a gasket, preferably of rubber or other suitable elastomer, natural or synthetic, the outer rim or annular portion of which may be relatively thin, generally in the order of .050" but the central portion of which is substantially thicker. Especially for containers, the rims of which are in the order of substantially more than 10 mm. in diameter, it is preferable that the central portion, usually a concentric circular portion, protrude substantially equally from opposite faces of the annular portion. Thus, the overall thickness of the central or thicker portion of the rubber gasket may be of the order of .130", a thickness adequate for re-sealing after puncture by the needle of a hypodermic syringe used in withdrawing parts of the contents from the bottle.

The cap is preferably a unitary sheet metal stamping, desirably of aluminum, with facilities for access to the central thicker part of the gasket to permit introduction of the needle of a hypodermic syringe through the gas ket for withdrawal of some of the biologic preparation from the bottle. For this purpose, the cap preferably includes (a) an outer annular portion with a dependent skirt to be crimped to, generally under the bead about the rim of the bottle neck, and (b) a central disc which may be of diameter in the order of that of the bore of the bottle mouth. The central disc is severable, preferably by resort to two or more spaced short narrow bridges connecting the outer periphery of the disc to the inner periphery of the outer annular portion of the cap. The rim of the disc has finger-nail grip portions by which it may be pried upwardly to sever the bridges for removal of the disc for access of the needle, for the purpose above stated. The annular portion of the cap overlies the rim portion of the gasket, and the severable central disc portion of the cap is appropriately spaced from the general plane of the annular portion of the cap to accommodate the outer thickened portion of the gasket.

More especially for bottles, the necks of which are of small diameter in the order of 10 to 15 mm. in diameter, it is preferable to provide the thickening of the gasket all at its inner face, leaving its outer face substantially flat, in which case the severable disc of the cap may extend substantially flush with the annular portion.

Where the gasket and cap are pre-assembled prior to application to a bottle, especially to a bottle of wide mouth, the thickening of the gasket might be all at the outer face of the gasket rim.

In the accompanying drawings in which are shown one or more of various possible embodiments of the several features of the invention,

Fig. 1 is a plan view of one embodiment of the bottle p,

Fig. 2 is a sectional view taken on the line 2-2 of Fig. 1,

Fig. 3 is a sectional view taken on the line 33 of Fig. 1,

Fig. 4 is a sectional view showing a fragment of the neck of the bottle with the closure applied thereto,

Fig. 5 is a view similar to Fig. 1, of a modified form of the invention;

Fig. 6 is a sectional view taken on line 6-6 of Fig. 5,

Fig. 7 is a sectional view taken on the line 77 of Fig. 5,

Fig. 8 is a view similar to Fig. 1, of still another embodiment of the invention,

Fig. 9 is a sectional view taken on line 9-9 of Fig. 8,

Fig. 10 is a sectional view taken on line 10-10 of Fig. 8,

Fig. 11 is a view similar to Fig. 4, of a longitudinal section of a further modified form of the invention as applied more particularly to a bottle of a very small neck bore, and

Fig. 12 is a sectional view showing a fragment of another embodiment.

Referring now to Figs. 1 to 4 of the drawings, the closure cap embodies a gasket 12, preferably of a suitable formulation of natural rubber, though suitable synthetic elastom-er r blends thereof, including or excluding natural rubber, may serve for some uses. All such materials are embraced within the term elastomer as used in certain of the claims. The gasket has an outer rim or annular portion 13 of relatively small thickness, which ordinarily may be in the order of .050" in thickness. That thickness is adequate for effecting a complete seal against the rim of the bottle neck 14 when the skirt 15 of a unitary sheet metal cap 16 of aluminum or other suitable material is crimped in place at under the head 17 around the rim of the bottle B.

The central portion of the gasket is of much greater thickness, preferably in the order of .130" which is ordinarily required to assure adequate automatic re-seal of the puncture made by the needle of a hypodermic syringe inserted for effecting removal of part of the contents from the bottle. Desirably, as shown, the thickened portion of the gasket is symmetrical with respect to the annular portion, one half, i.e., about .040 protruding inward at 18 from the under face of the rim 13, and the other, i.e., .040" protruding outward as at 19 from the outer face of the rim 13.

The cap 16 has a face from the outer periphery of which the skirt 15 extends downward, to be crimped for assembly, as at 20, under the bead 17 about the bottle neck. The face of the cap includes an outer annular portion 21 which engages the outer face of the annular or rim portion 13 of the gasket. The cap affords facilities for access of the needle of a hypodermic syringe to puncture the thickened central portion of the gasket. For this purpose the cap may have a central opening. Preferably, however, the face of the cap includes a severable central disc portion 22 which overlies the thickened central portion, desirably a concentric circular portion of the gasket. In the embodiments of Fig. 1 to 10, the disc portion 22 lies well above the outer face of the annular portion 21. Two bridging connections 23 and 24, desirably diametrically opposed, connect the outer periphery of the disc 22 with the inner periphery of the annular portion 21, the disc 22 being otherwise disconnected with respect to annulus 21 of the cap. The annulus 21 of the cap has an inner upstanding peripheral ledge 25 encompassing the outwardly protruding thickened central portion 19 of the gasket, the bridges 23 and 24 being integral with and extending diametrically inward from said peripheral ledge. Midway between the bridges 23 and 24, the severable disc 22 is desirably notched upward as at 26 for convenience of introduction of the finger nail by the physician, to break the narrow bridges 23 and 24 for removal of the severable disc portion 22 of the cap. To stiffen the severable disc 22, so as to facilitate severance without undue distortion, the disc 22 has a concentric circular rib 27 embossed therein, and if desired, there may be segmental peripheral embossments 27' extending between the bridges 23, 24 and the finger grip notches 26 on the severable disc 22.

In use of the present invention, the gasket which is devoid of any hollow portions may be readily and completely washed or sterilized apart from the cap and readily applied to the mouth of the bottle that has previously been charged with the sterile biological product. In that application, the lowermost thickened portion 18 of the gasket protrudes into the bottle neck, as best shown in Fig. 4, and serves as a pilot to center and position the gasket, but the fit is so loose within the bottle neck, as shown in Fig. 4, that the air displaced by the gasket readily escapes from the bottle without being compressed. The cap (which obviously need not be washed or sterilized), is then applied over the gasket, and downward pressure against the cap presses the rim of the gasket against the rim of the bottle, and the gasket rim is thus held compressed after the edge of the skirt 15 has been crimped, as at 20, under the bead of the bottle neck.

In use, the physician pries his finger nail or a suitable tool at one of the raised portions 26 of the severable central disc 22 of the cap, to sever the thin narrow bridges 23 and 24 for removal of the disc 22. After swabbing the thus exposed central portion of the gasket 12 with alcohol or the like, to obviate any infection caused in the removal of the severable disc 22, the physician punctures the central exposed area of gasket 12 with the needle of a hypodermic syringe, drawing into the syringe the desired charge of the biologic material, and as the needle is removed from the gasket 12, the gasket immediately contracts to close up the hole made by the needle so as to maintain the remaining contents thoroughly sterile. All that is required is for the physician to swab that area with alcohol or the like, preparatory to puncturing it again with the needle of a hypodermic syringe for withdrawal of a further charge of biologic material from the bottle.

In the embodiment of Figs. 5 to 7, the general construction described resembles that of Figs. 1 to 4, but the peripheral ledge 25' shown in Figs. 1 to 4 is omitted, the bridges 23' and 24 alone protruding upwardly from the inner periphery of the annular portion 21 of the cap to the outer periphery of the central severable disc 22. Thus substantially the entire periphery of the central disc 22 is spaced above the peripheral portion of the cap, as well as from the gasket for ready access of the finger nail of the physician to sever the bridges and remove the severable disc, without the need for any specialized conformation to accommodate the finger nail.

The embodiment of Figs. 8 to 10 shows a further modification of the invention, generally similar to the previously described embodiments, except that the central or severable portion 22 of the cap is downwardly dished at its periphery to encompass the central outwardly protruding thickness of the gasket and presents a rim portion 22*, the lower part of which substantially engages the gasket rim 13 The bridges 23 and 24 extend radially outward over the gasket rim from the rim 22 of the dished central disc 22 which is in contact with said gasket. The finger nail notches 26 which also extend radially outward from the gasket rim engaging edge of the dished central disc are shown midway between the bridges 23 and 24 for facility of removing the severable disc 22 of the cap.

In this embodiment, a somewhat larger area of the gasket will be exposed than in the embodiments of Figs. l to 7, upon removal of the severable disc 22 of the cap. To assure nevertheless an adequate seal between the cap and the bottle rim after removal of the disc 22 the annular portion 21 of the cap is preferably provided with a concentric downwardly embossed groove 32 that presses against the peripheral portion 13 of the gasket 12 In the embodiment of Fig. 11 that serves preferably for bottles with necks of very small diameter bore, the thickening of the gasket 12 at the central portion is all at the inner face as at 35, of the rim 13 of the gasket, the other face of the gasket being substantially flat, as shown. Thus the thickened portion 35 extends entirely into the neck of the bottle, but so loosely as in Fig. 4 that the air that would otherwise be compressed in insertion of the washer readily escapes. The cap is similar to those of the other embodiments, except that the severable disc portion 22 is substantially flush with the annular portion 21 of the cap so as to come into the same relation with the flat outer face of the gasket as does the severable disc portion in the other embodiments in its relation to the raised outer face of the gaskets there shown. The finger nail notches may be midway between the diametrically opposed bridges (not shown), or may be dispensed with by raising the outer edge of the severable disc portion 22 as at 26 at the outer periphery of an inwardly embossed peripheral groove at the outer edge of the severable disc 22 The embodiment of Fig. 11 is used with small bottles of neck diameter of the order of to mm. because of the difficulty Within the small space limits afiorded, of conforming the cap with its severable portion in the manner shown in the other embodiments.

In the fragmentary view of Fig. 12 is shown a closure in which the gasket is pre-assembled to the cap prior to application upon the bottle. It is an embodiment that may find utility, more especially with bottles of neck diameter well in excess of mm. Here the thickened central portion 35 of the gasket 12 protrudes wholly upward from the outer face of the gasket rim 13 for by reason of the pre-assembly of the gasket to the cap, no inwardly protruding thickened portion is needed to hold the disc in place on the bottle during application of the cap. While the cap is here shown as similar to that 'of the embodiment of Figs. 1 to 3, it may be of the embodiments of Figs. 5 to 7, or of Figs. 8 to 10.

In the embodiments of Figs. 1 to 10, the gasket is quite symmetrical so that either side may be downward in elfecting the assembly, while in the embodiments of Figs. 11 and 12, special means or precautions must be provided to assure that the gasket is applied to the bottle with its thickened central portion 35 extending downward, or in the embodiment of Fig. 12 with its central portion 35 extending upward into the cap.

In each embodiment, the gasket, as held in place by the cap, afiords a superior seal since the thin rim of the gasket is securely held against the rim of the bottle and the thicker central portion of the gasket will not be deformed by the pressure of the cap against the rim.

In various embodiments, the reference numerals of corresponding parts are in general the same as those of the embodiment of Figs. 1 to 4, with exponents 1, 2, 3 and 4, respectively.

The term bottle as used in the specification and claims, embraces within its scope an ampoule, a vial or other suitable container for biologic materials.

As many changes could be made in the above construction and many apparently widely different embodiments of this invention could be made without departing from the scope of the claims, it is intended that all matter contained in the above description or shown in the 6 accompanying drawings, shall be interpreted as illustrative and not in a limiting sense.

Having thus described my invention, what I claim as new and desire to secure by Letters Patent of the United States is:

1. A bottle closure of the character described comprising an imperforate gasket of resilient material with a thinner annular rim area for engaging the rim of a bottle and a thicker pilot portion substantially concentric with and protruding below the bottom face of said rim area and into the neck of the bottle, the maximum diameter of said thicker portion of the gasket being less than the bore diameter of said bottle neck, thereby loosely extending into said neck, said closure including a cap encompassing the gasket and having a skirt adapted to be secured to the mouth of such bottle and to hold the thinner rim area of the gasket compressed against the lip of the bottle with the thicker portion of the gasket free from sealing engagement with the bottle neck, said cap having a central severable disk portion, of diameter substantially less than the outer diameter of the cap, said disk portion having bridges integrally connecting the same to the body of the cap, whereby upon tearing out the central severable disk portion, the remaining portion of the cap will maintain the gasket in place against the rim of the bottle and the thicker portion of the gasket will be exposed for insertion of the needle of a hypodermic syringe therethrough.

2. The combination recited in claim 1 in which the thickness of the rim portion of the gasket is in the order of .050" and that of the central portion is in the order of .130".

3. The combination recited in claim 1 in which the thicker portion of the gasket extends symmetrically below and above the remaining area of said gasket.

References Cited in the file of this patent UNITED STATES PATENTS 1,431,871 Burnet Oct. 10, 1922 2,072,853 Baxter Mar. 9, 1937 2,135,386 Crabbe Nov. 1, 1938 2,295,658 Hogg Sept. 15, 1942 2,387,955 Tilson Oct. 30, 1945 2,665,024 Putz Jan. 5, 1954 FOREIGN PATENTS 131,822 Great Britain Sept. 4, 1919 969,469 France May 24, 1950 1,071,650 France Mar. 10, 1954 

